Comparison of the sedation effect of propofol with lidocaine spray versus isolated propofol admission during upper GI endoscopy in elective and outpatient patients
Comparison of the sedative effect of propofol with lidocaine spray and propofol alone in upper gastrointestinal endoscopy
Design
A randomized clinical trial without control group, with parallel groups, phase 3، without blindness that, 160 patients randomly divided into two groups of 80 subjects with block sizes of 4 and 6.
Settings and conduct
The population of this study was aged 20-65 years old who referred to Ayatollah Rouhani Hospital in Babol.Patients randomly divided into two Intervention groups with block sizes of 4 and 6.Intervention group1: propofol (Razavi Pharmacy) at a dose of 50 μg/kg Intervention group2: propofol at a dose of 50 μg/kg and a total of 3 puffs of 10% lidocaine spray (Caspian Tamin company) to the throat and to the tip of the endoscope tube
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients aged 20 to 65 years
Patients requiring upper gastrointestinal endoscopy
Exclusion criteria: Psychological disease, Addiction, Anemia, Obesity, Swallowing Disorders (Myasthenia gravis and Alzheimer's), Cardiac Disease, Low blood pressure, Bradycardia, Hepatic Failure, Kidney Disease.
Intervention groups
Intervention group1: propofol (Razavi Pharmacy) at a dose of 50 μg/kg
Intervention group2: propofol at a dose of 50 μg/kg and a total of 3 puffs of 10% lidocaine spray (Caspian Tamin company) to the throat and to the tip of the endoscope tube
Main outcome variables
Dosage of propofol؛ nausea, vomiting؛ instability of vital signs؛ respiratory distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200526047573N1
Registration date:2020-10-20, 1399/07/29
Registration timing:retrospective
Last update:2020-10-20, 1399/07/29
Update count:0
Registration date
2020-10-20, 1399/07/29
Registrant information
Name
Alma Bigdeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8301
Email address
dr.a.bigdeli67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
2020-04-20, 1399/02/01
Actual recruitment end date
2020-06-21, 1399/04/01
Trial completion date
2020-06-21, 1399/04/01
Scientific title
Comparison of the sedation effect of propofol with lidocaine spray versus isolated propofol admission during upper GI endoscopy in elective and outpatient patients
Public title
The effect of lidocaine spray to decrease propofol dosage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient age between 20 to 65 years old
Patients requiring upper gastrointestinal endoscopy
Samples will be randomly divided into two groups. In this study, coin toss will be used to generate a random sequence in the trial. So that one of the study groups is head and the other is the tail, and based on the sample size, the same number of coins will be thrown, and the individuals will be randomly assigned to two groups. Group tail patients will be treated with propofol with lidocaine spray and heads treated with propofol
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of babol University of Medical Sciences
Street address
Babol Medical University., Ganj Afrouz Blvd., Babol Town,
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.346
Health conditions studied
1
Description of health condition studied
Diseases of upper digestive system which need endoscopy
ICD-10 code
K25
ICD-10 code description
Gastric ulcer
Primary outcomes
1
Description
Propofol Dosage
Timepoint
At The End of Endoscopy
Method of measurement
Milligram per kilogram
2
Description
Nausea and Vomiting
Timepoint
At The End of Endoscopy
Method of measurement
Patient's clinical symptoms
3
Description
Respiratory Distress
Timepoint
At The End of Endoscopy
Method of measurement
Intercostal muscle retraction
4
Description
Heart Rate
Timepoint
At The End of Endoscopy
Method of measurement
Cardiac monitoring
5
Description
Blood Pressure
Timepoint
At The End of Endoscopy
Method of measurement
Non Invasive Blood Pressure Tools
Secondary outcomes
empty
Intervention groups
1
Description
propofol (Razavi Pharmacy) at a dose of 50 μg/kg
Category
Treatment - Drugs
2
Description
propofol at a dose of 50 μg/kg and a total of 3 puffs of 10% lidocaine spray (Caspian Tamin company) to the throat and to the tip of the endoscope tube
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani Hospital
Full name of responsible person
Alma Bigdeli
Street address
Rohani Hospital., Ganj Afrouz Blvd.,Babol Town.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3223 8301
Email
Ficu_ss@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Rohani Hospital., Ganj Afrouz Blvd.,Babol Town.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3223 8301
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Alma Bigdeli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Public Health
Street address
Rohani Hospital., Ganj Afrouz Blvd.,Babol Town.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3223 8301
Email
dr.a.bigdeli67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Alma Bigdeli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Public Health
Street address
Rohani Hospital., Ganj Afrouz Blvd.,Babol Town.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3223 8301
Email
dr.a.bigdeli67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Alma Bigdeli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Public Health
Street address
Rohani Hospital., Ganj Afrouz Blvd.,Babol Town.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3223 8301
Email
dr.a.bigdeli67@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available